Paper Contents
Abstract
In the present study, an attempt was made to develop a simple, precise, selective and sensitive validated bio analytical method of RIV using RP-HPLC. This method is quite simple, economic, less time-consuming method up to date for the determination of RIV in plasma with RP-HPLC. A reversed phase HPLC method has been successfully developed and validated for the determination of Rivaroxaban in raw materials and pharmaceutical dosage forms. Using isocratic elution, the method employs an optimized mobile phase consisting of 25 mM potassium phosphate mono basic buffer (pH2.9) and acetonitrile (70:30) at a flow rate of 1.0mLmin on an Agilent Technologies 1100 Series HPLC system equipped with an MWD (DAD) detector. The injection volume was set to 15L, and separation was achieved on a Thermo Hypersil ODS C18 column (4.6 250 mm, 5m) with detection at 249 nm at ambient temperature. The method was found to be simple, sensitive, specific, accurate, and repeatable, with no interference from excipients. It reliably achieve danLODof0.3 ppm, supported by a signal- to-noise ratio of 4.0, meeting the acceptance criterion of 3. Thorough validation following FDA and ICH guidelines confirmed the method's robustness and reliability across parameters such as system suitability, solution stability, specificity, robustness, linearity, accuracy, precision, LOD, and LOQ. This validated method, with its stability-indicating capabilities, is well-suited for routine quality control and analytical applications in both raw materials and finished drug products. Its simplicity, speed, and robustness make it an optimal choice for ongoing pharmaceutical analysis.
Copyright
Copyright © 2025 Sutare Nikhil Manoj. This is an open access article distributed under the Creative Commons Attribution License.
